HypertensionGABA2NCT02763930
Study of the Impact of Low Fat Dairy and High Fat Dairy Consumption on Daytime Ambulatory Blood Pressure
A study testing Milk diet and GABA-rich cheese diet in people with Hypertension, run by Laval University at 1 site in Canada.
Trial summary
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Milk diet and GABA-rich cheese diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women age between 18 and 75 years
- Average daytime systolic blood pressure ≥ 125 mmHg (blood pressure medication must be stopped 2 weeks before the start of the study).
- Stable weight for 3 months before the start of the study (+/- 5lbs)
Who cannot join
- Men or women aged under 18 years or over 75 years
- Average daytime systolic blood pressure ≥ 160 mmHg
- Average daytime diastolic blood pressure ≥ 110 mmHg
- History of cardiovascular disease, type 2 diabetes or dyslipidaemia monogenic
- Endocrine disorders
- Regular smoker
Show all 9Show fewer
- Lipid lowering medications or diabetes medications
- Food allergies and aversions to any food in the composition of experimental menus
- Subjects with special dietary habits (e.g. vegetarianism)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of Low Fat Dairy (Milk) and High Fat Dairy (Cheese) Consumption on Daytime Ambulatory Blood Pressure and Other Cardiometabolic Risk Factors
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of heart disease. Yet, a rather large body of recent evidence suggests that saturated fat may have been unfairly demonized and that its impact on the risk of heart disease may in fact be less important than originally thought. This concept that dairy fat increases the risk of heart attacks therefore needs to be revisited.
The proposed research is designed to investigate which risk factors for heart disease (e.g. cholesterol, blood pressure) are beneficially modified when low fat (milk) and high fat (cheese) dairy products are consumed.
Our hypotheses are : (1) Consumption of low fat dairy (milk 1% fat) compared with a dairy-free control diet reduces daytime ambulatory systolic blood pressure and reduces inflammation; (2) Consumption of a high fat dairy (GABA-rich cheese) compared with a dairy-free control diet reduces daytime ambulatory systolic blood pressure and has favorable effects on LDL particle size, inflammation and HDL-C concentration.
Read the detailed description
This is a single-center randomized crossover controlled feeding study. Briefly, adult men and women will be recruited based primarily on blood pressure criteria in the Quebec City metropolitan area through the media (newspaper, radio) and mailing lists (n=60).
Participants will be randomized to 3 experimental diets of 6 weeks each: 1- CONTROL dairy-free diet, 2- low fat dairy (MILK, 1% fat, 3 servings/d), 3- high-fat dairy (GABA-rich cheddar cheese, approximately 32% fat, 1 serving (50g)/d). Usual energy intake will be estimated at the beginning of the study using validated tools. Experimental diets will be provided as part of a full feeding protocol under carefully controlled isocaloric conditions to maintain body weight constant. All meals and foods will be provided to participants so that control for energy and macronutrient intake will be optimized. The breakfast meal will represent approximately 30% of the daily energy intake whereas the lunch and dinner meals each will provide 35% of daily energy intake. Participants will be instructed to consume their entire meals. A seven-day cyclic menu will be used. We have opted to test the impact of dairy intake over a 6-week period (as opposed to 4 or 5 weeks) to maximize the chance to observe clinically meaningful changes in blood pressure. Diets will be separated by a 4 to 8 week washout period. Randomization will be stratified by sex. Blood samples will be collected the day before each dietary phase and on 2 consecutive days after each dietary phase. The mean of the 2 consecutive measurements will be used in the analyses.
- Conditions
- Hypertension
- Being tested
- Control diet, Milk diet, GABA-rich cheese diet
- Keywords
- Cardiovascular disease, Blood pressure, Hypertension, Dairy products, Milk, Cheese
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control dietOther
Milk dietOther
GABA-rich cheese dietOther
| Study group | Role | What they receive |
|---|---|---|
| CONTROL (dairy-free) | Experimental | 6 weeks experimental diet with all meals and foods provided to participants. The diet contain 32% of fat, 11% of saturated fat (SFA), 13% of mono-unsaturated fat (MUFA), 8% of polyunsaturated fat (PUFA) and 15% of proteins. Receives: Other: Control diet |
| MILK (low fat dairy) | Experimental | 6 weeks experimental diet with all meals and foods provided to participants including 3 servings/day of milk (1% fat) per 2500 kcal. The diet contain 32% of fat, 11% of SFA, 13% of MUFA, 8% of PUFA and 15% of proteins. Receives: Other: Milk diet |
| GABA-rich cheese (high-fat dairy ) | Experimental | 6 weeks experimental diet with all meals and foods provided to participants including 50g/day of GABA-rich cheddar cheese (approximately 32% fat). The diet contain 32% of fat, 13% of SFA, 13% of MUFA, 6% of PUFA and 15% of proteins. Receives: Other: GABA-rich cheese diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in daytime ambulatory systolic blood pressure after dairy product consumption (Milk or GABA-rich cheese) compared with the control dairy-free diet.
Measured: 6 weeks (end-point value)
Secondary outcomes (6)
Variation in lipid concentrations (LDL-C, HDL-C, TG)
Measured: 6 weeks (end-point value)
Variation in apolipoprotein B (ApoB) concentration
Measured: 6 weeks (end-point value)
Variation in Low Density Lipoproteins (LDL) particle size
Post-diet values will be compared
Measured: 6 weeks (end-point value)
Variation in High Density Lipoproteins (HDL) particle size
Measured: 6 weeks (end-point value)
Variation in C-Reactive Protein (CRP) concentration
Measured: 6 weeks (end-point value)
Variation in Adiponectin concentration
Measured: 6 weeks (end-point value)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Dairy Farmers of Canada
- Responsible party
- Principal investigator, Benoit Lamarche, Laval University
- Investigators
- Benoit Lamarche, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763930
- Sponsor's protocol ID
- INAF-2015-268
- Acronym
- GABA2
- Status last verified
- Feb 2018
- First submitted
- 3 May 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rancourt-Bouchard M, Gigleux I, Guay V, Charest A, Saint-Gelais D, Vuillemard JC, Lamarche B, Couture P. Effects of regular-fat and low-fat dairy consumption on daytime ambulatory blood pressure and other cardiometabolic risk factors: a randomized controlled feeding trial. Am J Clin Nutr. 2020 Jan 1;111(1):42-51. doi: 10.1093/ajcn/nqz251.
PubMed 31584063
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Low Fat Dairy (Milk) and High Fat Dairy (Cheese) Consumption on Daytime Ambulatory Blood Pressure and Other Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT02763930
- Acronym / sponsor ID
- GABA2 / INAF-2015-268
- Conditions
- Hypertension
- Keywords
- Cardiovascular disease, Blood pressure, Hypertension, Dairy products, Milk, Cheese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, Dairy Farmers of Canada
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese consumption, with potentially important impact on this key industry in Canada. This is in part due to the commonly accepted notion that saturated fat in the diet, of which cheese contributes significantly, increases the risk of heart disease. Yet, a rather large body of recent evidence suggests that saturated fat may have been unfairly demonized and that its impact on the risk of heart disease may in fact be less important than originally thought. This concept that dairy fat increases the risk of heart attacks therefore needs to be revisited.
The proposed research is designed to investigate which risk factors for heart disease (e.g. cholesterol, blood pressure) are beneficially modified when low fat (milk) and high fat (cheese) dairy products are consumed.
Our hypotheses are : (1) Consumption of low fat dairy (milk 1% fat) compared with a dairy-free control diet reduces daytime ambulatory systolic blood pressure and reduces inflammation; (2) Consumption of a high fat dairy (GABA-rich cheese) compared with a dairy-free control diet reduces daytime ambulatory systolic blood pressure and has favorable effects on LDL particle size, inflammation and HDL-C concentration.
Detailed description
This is a single-center randomized crossover controlled feeding study. Briefly, adult men and women will be recruited based primarily on blood pressure criteria in the Quebec City metropolitan area through the media (newspaper, radio) and mailing lists (n=60).
Participants will be randomized to 3 experimental diets of 6 weeks each: 1- CONTROL dairy-free diet, 2- low fat dairy (MILK, 1% fat, 3 servings/d), 3- high-fat dairy (GABA-rich cheddar cheese, approximately 32% fat, 1 serving (50g)/d). Usual energy intake will be estimated at the beginning of the study using validated tools. Experimental diets will be provided as part of a full feeding protocol under carefully controlled isocaloric conditions to maintain body weight constant. All meals and foods will be provided to participants so that control for energy and macronutrient intake will be optimized. The breakfast meal will represent approximately 30% of the daily energy intake whereas the lunch and dinner meals each will provide 35% of daily energy intake. Participants will be instructed to consume their entire meals. A seven-day cyclic menu will be used. We have opted to test the impact of dairy intake over a 6-week period (as opposed to 4 or 5 weeks) to maximize the chance to observe clinically meaningful changes in blood pressure. Diets will be separated by a 4 to 8 week washout period. Randomization will be stratified by sex. Blood samples will be collected the day before each dietary phase and on 2 consecutive days after each dietary phase. The mean of the 2 consecutive measurements will be used in the analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL (dairy-free) | Experimental | Other: Control diet6 weeks experimental diet with all meals and foods provided to participants. The diet contain 32% of fat, 11% of saturated fat (SFA), 13% of mono-unsaturated fat (MUFA), 8% of polyunsaturated fat (PUFA) and 15% of proteins. |
| MILK (low fat dairy) | Experimental | Other: Milk diet6 weeks experimental diet with all meals and foods provided to participants including 3 servings/day of milk (1% fat) per 2500 kcal. The diet contain 32% of fat, 11% of SFA, 13% of MUFA, 8% of PUFA and 15% of proteins. |
| GABA-rich cheese (high-fat dairy ) | Experimental | Other: GABA-rich cheese diet6 weeks experimental diet with all meals and foods provided to participants including 50g/day of GABA-rich cheddar cheese (approximately 32% fat). The diet contain 32% of fat, 13% of SFA, 13% of MUFA, 6% of PUFA and 15% of proteins. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women age between 18 and 75 years
- Average daytime systolic blood pressure ≥ 125 mmHg (blood pressure medication must be stopped 2 weeks before the start of the study).
- Stable weight for 3 months before the start of the study (+/- 5lbs)
Key exclusion criteria (9 listed)
- Men or women aged under 18 years or over 75 years
- Average daytime systolic blood pressure ≥ 160 mmHg
- Average daytime diastolic blood pressure ≥ 110 mmHg
- History of cardiovascular disease, type 2 diabetes or dyslipidaemia monogenic
- Endocrine disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control diet | Other | CONTROL (dairy-free) |
| Milk diet | Other | MILK (low fat dairy) |
| GABA-rich cheese diet | Other | GABA-rich cheese (high-fat dairy ) |
Primary outcome
Variation in daytime ambulatory systolic blood pressure after dairy product consumption (Milk or GABA-rich cheese) compared with the control dairy-free diet.
Time frame: 6 weeks (end-point value)
6 secondary outcomes
Variation in lipid concentrations (LDL-C, HDL-C, TG)
Time frame: 6 weeks (end-point value)
Variation in apolipoprotein B (ApoB) concentration
Time frame: 6 weeks (end-point value)
Variation in Low Density Lipoproteins (LDL) particle size
Time frame: 6 weeks (end-point value)
Variation in High Density Lipoproteins (HDL) particle size
Time frame: 6 weeks (end-point value)
Variation in C-Reactive Protein (CRP) concentration
Time frame: 6 weeks (end-point value)
Variation in Adiponectin concentration
Time frame: 6 weeks (end-point value)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 31584063Rancourt-Bouchard M, Gigleux I, Guay V, Charest A, Saint-Gelais D, Vuillemard JC, Lamarche B, Couture P. Effects of regular-fat and low-fat dairy consumption on daytime ambulatory blood pressure and other cardiometabolic risk factors: a randomized controlled feeding trial. Am J Clin Nutr. 2020 Jan 1;111(1):42-51. doi: 10.1093/ajcn/nqz251.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Lamarche, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk diet and GABA-rich cheese diet in people with Hypertension, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in daytime ambulatory systolic blood pressure after dairy product consumption (Milk or GABA-rich cheese) compared with the control dairy-free diet. (time frame: 6 weeks (end-point value)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.